Why release a new version of an old drug?

On June 18, 2007, Cephalon announced FDA approval for Nuvigil (armodafinil), a non-amphetamine wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). But don’t expect to see it on the market anytime soon! That’s because the drug is essentially the same as their currently marketed product called Provigil (modafinil). Want some insight into what this is all about? Read on.

When a drug company has a successful product, they get very concerned when it gets close to the time for patent expiration because it means that cheap generic equivalents will soon appear. There are any number of strategies that companies use to protect their interests in this situation, and one of the most common is to take a look at the drug’s chemistry to see if there’s anything there to exploit. One possibility is to reformulate the product into something that lasts longer than the original, so you’ll see things like extended-release or controlled-release formulations being developed. Another typical strategy is to look at the drug’s chemical forms, called isomers.

Without getting too deeply into it, many chemicals have two isomers and in many cases only one of them is actually active. So a common strategy is to see whether a new drug can be created that contains only the active isomer. You’ve probably heard of Nexium (“the purple pill”), which is the active isomer of what was previously sold as Prilosec. There are many other examples.

So the people at Cephalon were starting to worry about their patent on Provigil because there were a number of lawsuits pending from generic drug manufacturers eager to get the rights to sell it. And it turns out that Provigil does have two isomers. In this particular case, they are both active, but one is eliminated from the body much more quickly than the other, so essentially the activity really comes from one isomer. Hence the development of Nuvigil, the longer-acting isomer formulation of Provigil.

So why won’t you see it on the market? Because along the way, Cephalon successfully defended their Provigil patents and avoided generic competition until sometime around 2011. So now they have their generic protection product approved but don’t really need it yet. Here’s the telling line from their press release: “The company currently plans a commercial launch of NUVIGIL once additional clinical data has been amassed.” Further, “The approval of NUVIGIL allows us to preserve our current leadership position in the area of wakefulness,” said Frank Baldino, Jr., Ph.D., Chairman and CEO, Cephalon. “More importantly, we now have a longer-term opportunity to further characterize the utility of this compound beyond wakefulness.” When they say “preserve our current leadership position,” that means continue to sell Provigil. When they say “longer-term opportunity,” that means, they’ll launch it when they feel the timing is better suited to a generic protection strategy. (Read the full press release.)

So here’s what will happen. In a year or two, Cephalon will launch Nuvigil. They will advertise it as being the newest product available for its intended uses. The “Nu” in Nuvigil is there for a reason, after all. They will attempt to get as many current Provigil users switched to Nuvigil by appealing to people’s inherent preference for all things new and different. Once a person has been switched to Nuvigil, the fact that a generic version of Provigil comes out will be irrelevant. Only if you are still on Provigil would your pharmacy or insurance program force you to buy a generic form.

Everything I’ve written above describes practices that are common, legal and totally appropriate for the manufacturer. All drug companies do this and I’m only singling out Cephalon because they just happened to get an approval that caught my eye, and I thought would make an interesting story because they aren’t bothering to actually sell the product yet. Whether or not this is or isn’t a good thing for society is a subject for another day.

Oh, if you’re wondering about the Nuvigil patent, it doesn’t expire until 2023!

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ABOUT THE AUTHOR

Ed Zimney, MD

Ed is a physician with more than 30 years of experience. He’s held positions in drug advertising review, drug safety surveillance, medical information and marketing with several bio/pharmaceutical companies.